Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
As per the present regulatory scenario the method for Quality Control of Doravirine (DRN) was optimized with Analytical Quality by design (AQbD) approach. Experimental data is procured by Full factorial design in Design Expert software with three critical process parameters flow rate, aqueous mobile phase ratio and wavelength. The dependent critical quality attribute for the above process parameters were theoretical plates, retention time and capacity factor. The optimized chromatographic conditions were BDS (150×4.6 mm, 5μm) kromasil column, mobile phase of mixture of buffer-potassium hydrogen phosphate and acetonitrile (65: 35 v/v) with flow rate 1.0ml/min. The ICH guidelines were considered for method validation.. The method was linear between concentration and peak area with the range of concentration 5-30 μg/ml. The detection and quantitation limits were found to be 0.02 μg/ml and 0.07 μg/ml respectively. The DRN was retained at 2.2 min with maximum absorbance wavelength 272.0 nm. Several stress conditions like hydrolytic (acid, base, neutral), oxidative, thermal and photolytic were exposed on the drug to study the degradation pattern. Degradation was more in basic condition. So the developed method was robust, accurate, sensitive and stability indicating and the developed method can be used for routine analysis. The method was extended to analyse the drug in the presence of degradants.